FDA.reportPublic FDA data

Coulmed

Primary DI
10810087351110
Brand
Coulmed
Company
Coulmed Products Group LLC
Model
GP159-5
Catalog number
GP159-5
Device description
Pediatric Gel Padded Ankle Straps for Candy Cane Stirrups, Size: 3/8' x 1-7/8' x 12-1/2', per pair
Published
2023-01-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
PRNPediatric position holder

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PRNPediatric Position HolderGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30810087351114PackageGS12In Commercial Distribution
10810087351110PrimaryGS10
00810087351113Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3081008735111430810087351114
1081008735111010810087351110
00810087351113008100873511138100873511130810087351113

GMDN Terms#

Term, Definition table
TermDefinition
Operating table patient positioning set, reusableA collection of devices intended to support and stabilize in a desired position a patient, or their body parts, on an operating table during a medical procedure (e.g., bariatric surgery, orthopaedic surgery, endotracheal tube intubation); some types may be intended to prevent a patient from sliding while in the Trendelenburg position or when applying traction. The set consists of multiple items which include two or more of the following: a base plate/bar that serves as a foundation to which patient positioners are attached, clamps/adaptors, and disposable/reusable padded positioners dedicated to a body part (e.g., non-slip positioning pad, headrest). This is a reusable device.

Regulatory Flags#

DUNS number
047115479
Device count
2
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10810087352605CoulmedAC28-PAC28-P2023-01-06
10810087352612CoulmedAC3300-BPAC3300-BP2023-01-06
10810087352629CoulmedAC3400-BPAC3400-BP2023-01-06
10810087352636CoulmedAC3800-BPAC3800-BP2023-01-06
10810087352643CoulmedAC3800-BP-LAC3800-BP-L2023-01-06
10810087352650CoulmedAC3800-BP-RAC3800-BP-R2023-01-06
10810087352667CoulmedAC3900-BPAC3900-BP2023-01-06
10810087350007CoulmedDI-5403DI-54032023-01-06
10810087350014CoulmedDI-5404DI-54042023-01-06
10810087350021CoulmedDI-5406DI-54062023-01-06
10810087350038CoulmedDI-5408DI-54082023-01-06
10810087350045CoulmedDI-5414DI-54142023-01-06
10810087350052CoulmedDI-5415DI-54152023-01-06
10810087350069CoulmedDI-5416DI-54162023-01-06
10810087350076CoulmedDI-5419DI-54192023-01-06
10810087350083CoulmedDI-5420DI-54202023-01-06
10810087350090CoulmedDI-5424DI-54242023-01-06
10810087350106CoulmedDI-5503DI-55032023-01-06
10810087350113CoulmedDI-6101DI-61012023-01-06
10810087350120CoulmedDI-6102DI-61022023-01-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
20888277668000MEDLINEMEDLINE INDUSTRIES, INC.PRN2025-02-13
10888277668003MEDLINEMEDLINE INDUSTRIES, INC.PRN2025-02-13
04260764840557MedibinoNEO ring – TG PUR Gel - Size L - PU 6Kluba Medical GmbHPRN2024-09-06
04260764840571MedibinoNEO ring – TG PUR Gel - Size S - PU6Kluba Medical GmbHPRN2024-09-06
04260764840649MedibinoNEO disposable Cover cotton knit WITHOUT soft granules - Size L - PU50Kluba Medical GmbHPRN2024-09-06
04260764840656MedibinoNEO disposable Cover cotton knit WITHOUT soft granules - Size M - PU50Kluba Medical GmbHPRN2024-09-06
04260764840663MedibinoNEO disposable Cover cotton knit WITHOUT soft granules - Size S - PU50Kluba Medical GmbHPRN2024-09-06
04260764840670MedibinoNEO disposable cover cotton knit WITH soft granules - Size L - PU 50Kluba Medical GmbHPRN2024-09-06
04260764840687MedibinoNEO disposable cover cotton knit WITH soft granules - Size M - PU50Kluba Medical GmbHPRN2024-09-06
04260764840694MedibinoNEO disposable cover cotton knit WITH soft granules - Size S - PU50Kluba Medical GmbHPRN2024-09-06
04260764840564MedibinoNEO ring – TG PUR Gel - Size M - PU6Kluba Medical GmbHPRN2024-09-06
04260764840823MedibinoNEO disposable cover cotton knit WITH soft granules - Size L - PU 50Kluba Medical GmbHPRN2024-09-06
04260764840830MedibinoNEO disposable cover cotton knit WITH soft granules - Size M - PU50Kluba Medical GmbHPRN2024-09-06
10810087355965CoulmedCoulmed Products Group LLCPRN2023-02-07
10810087350861CoulmedCoulmed Products Group LLCPRN2023-01-06
10810087351165CoulmedCoulmed Products Group LLCPRN2023-01-06
10810087351196CoulmedCoulmed Products Group LLCPRN2023-01-06
10810087351240CoulmedCoulmed Products Group LLCPRN2023-01-06
10810087351349CoulmedCoulmed Products Group LLCPRN2023-01-06
10810087351356CoulmedCoulmed Products Group LLCPRN2023-01-06
10810087351363CoulmedCoulmed Products Group LLCPRN2023-01-06
10810087351370CoulmedCoulmed Products Group LLCPRN2023-01-06
10810087351677CoulmedCoulmed Products Group LLCPRN2023-01-06
10810087351684CoulmedCoulmed Products Group LLCPRN2023-01-06
10810087351691CoulmedCoulmed Products Group LLCPRN2023-01-06
10810087351707CoulmedCoulmed Products Group LLCPRN2023-01-06
10810087351714CoulmedCoulmed Products Group LLCPRN2023-01-06
10810087351721CoulmedCoulmed Products Group LLCPRN2023-01-06
10810087351899CoulmedCoulmed Products Group LLCPRN2023-01-06
10810087351905CoulmedCoulmed Products Group LLCPRN2023-01-06